Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children

April 17, 2012 updated by: Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention

A Phase I Clinical Trial for Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Children

Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective, 90-99% of children will produce antibody of protection after 3 doses. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.

Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.

According to the present immunization schedule, to reach the median level of antibody levels there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity, to provide high levels of long-term protection and to reduce the number of injections.

The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects aged from 6 months to 5years old of normal intelligence
  • The subjects'guardians are able to understand and sign the informed consent
  • Subjects established as healthy after medical history questioning,physical examination and clinical decision and in accordance with vaccination requirements of the experimental vaccine
  • Subjects who can comply with the requirements of the clinical trial program according to the researcher's views
  • Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine
  • Subjects with temperature <37°C on axillary setting

Exclusion Criteria:

Exclusion Criteria for the first dose:

  • Subject who has a medical history of Meningitis
  • Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on
  • Subject who is allergic with tetanus toxoid components
  • Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection
  • Subject who has a history of allergic reactions
  • Any known immunological dysfunction
  • Had received gamma globulin or immune globulin, in the past two weeks
  • Subject suffering from congenital malformations, dysgenopathy or serious chronic disease
  • Any acute infections
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Exclusion Criteria for the second dose:

  • Had any Grade 3 or Grade 4 adverse reactions or events
  • Any situation meets the exclusion criteria stated in the exclusion criteria for first dose
  • Any condition the investigator believed may affect the evaluation of the vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: children aged 2-5 years (1 dose)
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 2-5 years, on day 0
Biological: 0.5ml/dose for a person
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0
Biological: 0.5ml/dose for a person
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28
Experimental: children aged 6-23months (2 doses)
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccines of 0.5ml/dose for a person in 20 children aged 6-23 months old, on day 0, 28
Biological: 0.5ml/dose for a person
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0
Biological: 0.5ml/dose for a person
group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adverse reactions in healthy children (2-5 years) after the first vaccination
Time Frame: 7 days after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (2-5 years) after the first vaccination
7 days after the first vaccination
The adverse reactions in healthy children (6-23 months) after the first vaccination
Time Frame: 7 days after the first vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the first vaccination
7 days after the first vaccination
The adverse reactions in healthy children (6-23 months) after the second vaccination
Time Frame: 7 days after the second vaccination
to evaluate the adverse reactions of the group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine in healthy children (6-23 months) after the second vaccination
7 days after the second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Royal (Wuxi) Biological Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 17, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JSVCT006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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